MITEK THREADED ANCHOR (FASTIN)— 510(k) K953560

Substantially Equivalent for Some Indications

Mitek Surgical Products, Inc.

FDA 510(k) clearance K953560 for MITEK THREADED ANCHOR (FASTIN), Substantially Equivalent for Some Indications on 1996-01-31. Applicant: Mitek Surgical Products, Inc..

Clearance details

Applicant: Mitek Surgical Products, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 1995-07-20
Decision date: 1996-01-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.